N/A
N=41
Self-Management of Chronic Depressive Symptoms in Pregnancy
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02953990 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Recruitment Data — 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MOMS Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Data |
41 | — |
| PRIMARY Retention Data |
27 | — |
| PRIMARY Adherence |
26 | — |
| PRIMARY Completed Interviews |
26 | — |
| PRIMARY Edinburgh Postnatal Depression Scale (EPDS) |
15.2; 5.05 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ9) |
13.54; 5.05 | — |
| SECONDARY State-Trait Anxiety Inventory-State (STAI-S) |
50.02; 36.04 | — |
| SECONDARY Ruminations Response Scale (RRS-10) |
26.63; 23.14 | — |
| SECONDARY Self-Efficacy for Physical Activity |
26.04; 28.6 | — |
| SECONDARY Maternal Fetal Attachment Scale (MFAS) |
54.56; 43.97 | — |
| SECONDARY Baby's Birth Weight |
7.57 | — |
| SECONDARY Stress |
25.27; 16.72 | — |
| SECONDARY Total # of Minutes in Physical Activity (Including Yoga) |
141 | — |
Summary
This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. Ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.
Eligibility Criteria
Inclusion Criteria
- ≥ age 18;
- self-report of depressive symptoms prior to pregnancy;
- current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the Patient Health Questionnaire-9;
- able to read, write, and understand English;
- self-identify as black/African American (AA) or White;
- absence of suicidal ideations (measured as low risk on the M.I.N.I. Neuropsychiatric Interview tool);
- absence of pregnancy complications/physical conditions making physical activity (PA) inadvisable;
- has not engaged in a consistent mindfulness-based PA routine during the pregnancy (such as yoga or similar activities more than once per month).
Exclusion Criteria
- If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
Data sourced from ClinicalTrials.gov (NCT02953990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.